Surgical Site Infections
Conditions
Interventions
Trade Name: Cefazolin
Product Name: Cefazoline Mylan
Pharmaceutical Form: Powder for injection
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aged between 18 and 75 years - Scheduled for IR following fracture surgery of the patella, lower leg, ankle or foot Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 632 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: - Removing and re-implanting osteosynthetic material in the same session - Active wound infection or (plate) fistula - Antibiotic treatment at time of IR for a concomitant disease or infection - A medical history of severe hypersensitivity to penicillin or any other beta-lactam antibiotic - Severe kidney insufficiency (eGFR < 35) - Pregnancy and lactation - Treatment with probenecid, anticoagulants (see SPC) - Immunosuppressant use in organ transplantation or rheumatoid joint disease - Insufficient comprehension of the Dutch/English language to understand the patient information to make an informed decision to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to study the effectiveness of a single intravenous dose of 2g of cefazolin on SSIs after IR following fixation of foot, ankle and/or lower leg fractures. ; Secondary Objective: Secondary Objective(s): - To study the cost-effectiveness of 2g of cefazolin preventing SSIs after IR - To elucidate the underlying mechanism of antibiotic prophylaxis by measuring tissue oxygenation and target-site concentrations of cefazolin - To identify possible underlying infections (before IR) - To identify independent predictors of SSI ; Primary end point(s): The primary outcome parameter is SSI within 90 days, as defined by the criteria used in the latest CDC guideline for the prevention of SSI. ;Timepoint(s) of evaluation of this end point: At 2 weeks, 6 weeks, 3 months and 6 months after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes include: - Cost-effectiveness of intervention: measured with health care resource utilization and costs (iMCQ, iPCQ); at baseline, 6 weeks, 3 months and 6 months after surgery and using quality adjusted life years (QUALY's), measured by the 5-level EuroQuality of Life-5D (EQ-5D-5L); at baseline, 2 weeks, 6 weeks, 3 months and 6 months after surgery - target-site antibiotic concentrations: The time that target site concentrations of prophylactic cefazolin stay above the minimal inhibitory concentration needed to adequately prevent SSIs (T>MIC) will be measured during surgery from at least two samples at varying time points in blood and soft tissue from incision site. In addition, the concentration of cefazolin will be measured in serum, to construct a multi-compartment pharmacokinetic model (only selected patients) - tissue oxygenation: Measured during surgery by a micro-catheter in the tip of a flexible probe inserted in the subcutaneous tissue of the contralateral ankle (only selected patients). - underlying infections: diagnosed by analyzing the presence of pathogens on removed implants, determined by culture of removed material (only Amsterdam UMC); directly following surgery - independent predictors of SSI, measured by a multivariate regression analysis/subgroup analysis of patient and treatment characteristics (e.g. weight, smoking) ;Timepoint(s) of evaluation of this end point: At 2 weeks, 6 weeks, 3 months and 6 months after surgery | — |
Countries
Netherlands
Outcome results
None listed